Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-01-01 @ 12:21 AM
Study NCT ID:
NCT04912908
Status:
COMPLETED
Last Update Posted:
2022-11-18
First Post:
2021-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Surgical Navigation Algorithm During Knee Replacements in Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-17', 'studyFirstSubmitDate': '2021-06-02', 'studyFirstSubmitQcDate': '2021-06-02', 'lastUpdatePostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of navigation algorithm', 'timeFrame': '12 months', 'description': 'Comparison between peroperative images and preoperative CT-scan'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'Ganymed Robotics develops a novel solution of surgical navigation to assist surgeons during knee remplacement surgeries. The aim of this study is to train and validate this novel algorithm.', 'detailedDescription': "During knee replacement surgery, per-operative images of the patient's knee will be taken. These images will then be compared with the pre-operative CT-scan of the patient using the novel navigation algorithm. The algorithm will be validated based on its ability to correctly compare both modalities (pre-operative and per-operative images)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The surgeons involved in the study will propose to all patients corresponding to the eligibility criteria to participate to the study during pre-surgery appointment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults patients who signed the ICF of the study\n* Patients suffering from knee osteoarthritis requiring a total knee replacement surgery\n\nExclusion Criteria:\n\n* Patient under the age 18\n* Patient unable to consent to the study or refusing to participate\n* Patient with history of knee replacement on the knee that will be operated again\n* Patient unable to realize a pre-operative CT-scan\n* Patient not covered by French Health insurance or equivalent.'}, 'identificationModule': {'nctId': 'NCT04912908', 'acronym': 'VALALGON', 'briefTitle': 'Validation of a Surgical Navigation Algorithm During Knee Replacements in Patients With Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ganymed Robotics'}, 'officialTitle': 'Validation of a Surgical Navigation Algorithm During Knee Replacements in Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': '2021-A00961-40'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Images taken during knee replacement surgery', 'type': 'OTHER', 'otherNames': ['CT-Scan before knee replacement surgery'], 'description': 'Images taken during knee replacement surgery will be compared to CT-Scan that was performed before surgery'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'facility': 'Hopital prive Jean Mermoz-Ramsay Santé', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ganymed Robotics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}